Website Ventyx Biosciences
This Job listing For Year 2022 is about Ventyx Biosciences in Raleigh-Durham-Chapel Hill Area
About the job
Ventyx Biosciences, Inc. is a clinical-stage, public biopharmaceutical company focused on advancing new therapies for millions of people living with inflammatory diseases and autoimmune disorders. We are developing novel and differentiated therapeutics that target both the innate and adaptive immune system. Our clinical-stage programs include an allosteric TYK2 inhibitor for the treatment of a broad range of autoimmune diseases, an S1P1 receptor modulator for the treatment of ulcerative colitis, and a peripheral inhibitor of the NLRP3 inflammasome, which is a mediator of multiple inflammatory conditions. Join this team of life science professionals to bring this portfolio of programs to fruition.
The Opportunity: Clinical Trial Manager/Senior Clinical Trial Manager
The Clinical Trial Manager (CTM) provides trial oversight of investigational sites, CROs and vendors (including both U.S. and Ex-U.S. regions) to deliver high quality data, ensure subject safety and rights and demonstrate compliance with GCP, regulations and other study related plans.
What You Will Contribute
- Oversees vendor (e.g., CRO, Biometrics, IRT, PK/Central Lab, eTMF, Safety, Clinical Supplies) for adherence to budget, timelines and organizational objectives and goals.
- Develops strong vendor relationships and ensures continuity of relationships through all phases of the trial.
- Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriateequired.
- Participates & provides oversight of site selection, including gathering feedback from other functions.
- Coordinates & manages various tasks in collaboration with other functions as needed.
- Ensures subjects’ rights, safety and well-being are protected.
- May conduct site oversight visits or co-monitoring visits.
- Performs timely review of monitoring reports and associated deliverables demonstrating sponsor oversight.
- Supports clinical document control activities and associated study staff to ensure the content and management of the electronic/paper Trial Master File (eTMF/TMF) is current and inspection ready.
- Performs periodic reviews of the eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Evaluates and resolves site performance, quality or compliance problems and escalates per defined process as appropriate in collaboration with clinical operations management.
- Contributes to team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriateequired.
- Tracks and coordinates trial related material availability, including clinical trial supplies and laboratory samples.
- Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Supports financial management of the study which includes review and approval of site and vendor invoices.
- Identifies risk and mitigates as appropriate.
- Supports audit/inspection activities as needed.
- Maintains clinical trial registry entry/updates, as required.
- Provides mentorship/guidance to less experienced team members or cross-functional colleagues on study processes/study requirements.
What We Seek
- BS/BA degree or AS degree in a health-related field (e.g., RN) and 2-5+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required.
- 2+ years’ experience in the described contributions.
- Must have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive.
- Excellent knowledge of clinical operations across Phase 1-3, specifically conducting clinical studies from start-up through close-out.
- Broad trial management protocol and process knowledge.
- Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
- Strong oral & written scientific communications skills.
- Good presentation skills for diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).
- Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team.
- Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.
- Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems; ability to work with large databases.
- Ability to travel if necessary.
What We Provide to You
- The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.
- Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
- Competitive compensation and a comprehensive benefit package, including stock options.
Job candidates should be aware that full vaccination against COVID-19 is required as a condition of employment subject to legally required exceptions. Ventyx is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.
Company: Ventyx Biosciences
Vacancy Type: Full-time
Job Location: Raleigh-Durham-Chapel Hill Area
Application Deadline: N/A